(187 days)
Not Found
No
The device is a physical barrier (transducer cover) and the description focuses on its material properties, dimensions, and barrier function. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
The device is described as a protective cover for ultrasound transducers, designed to provide a sterile barrier and prevent transmission of pathogens. It does not exert any therapeutic effect on the patient.
No
Explanation: The FreeeScan® Ultrasound Transducer Covers are protective covers designed to provide a sterile barrier for ultrasound transducers. They do not perform any diagnostic function themselves but rather facilitate the sterile use of a diagnostic device (ultrasound transducer).
No
The device is a physical product (transducer covers made of Chloroprene) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use of the FreeeScan® Ultrasound Transducer Covers is to provide a sterile barrier between the ultrasound transducer and the patient/healthcare worker. This is a physical barrier function, not a diagnostic one.
- Device Description: The device is described as a protective cover made of Chloroprene. Its function is to prevent the transmission of pathogens.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) or to provide information about a patient's health status through such analysis. IVDs are specifically designed for these purposes.
- Input Modality and Anatomical Site: While ultrasound is used for diagnosis, the cover itself is a protective accessory for the ultrasound equipment, not the diagnostic tool itself.
- Performance Studies: The performance studies focus on biocompatibility and barrier effectiveness, which are relevant to a protective medical device, not an IVD.
In summary, the FreeeScan® Ultrasound Transducer Cover is a medical device designed for infection control during ultrasound procedures. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The FreeeScan® Ultrasound Transducer Covers are protective covers applied to ultrasound transducers. These covers are designed to provide a sterile barrier between the non-sterile TXD's (and instrument guide adapters in some cases) and the patient/healthcare worker. The covers are intended for use during both sterile and non-sterile procedures using sector, linear, intravaginal and rectal transducers.
The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive. The transducer covers are supplied sterile or non-sterile and intended for single-use.
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
The FreeeScan® Ultrasound Transducer Cover provides a thin, conformal covering to fit various ultrasound transducer geometries. The device is manufactured as a one-piece design that provides a covering to prevent the transmission of pathogens, as the ultrasound transducer is reused from one patient to another.
The cover material is Chloroprene (synthetic rubber), which is similar to the non-latex material used in medical examination gloves or surgical gloves. Type I natural latex allergy does not occur in response to Chloroprene since the synthetic rubber does not contain the natural protein allergen which is present in latex.
Various sizes and shapes of covers are offered in order to fit different transducer geometries. The following product models are currently included (other shapes are likely to be added):
- . FreeeScan® 1 - W:3.4 cm, L:45-244 cm (Drawing 5500-000002-1B)
- FreeeScan® 4 W:10 cm, L:45-244 cm (Drawing 5500-000003-1B) .
- FreeeScan® 6 W:9.5/11.5 cm, L:45-244 cm (Drawing 5500-000004-1B) .
- . FreeeScan® 8 - W:7.5 cm, L:45-244 cm (Drawing 5500-000005-1B)
- FreeeScan® 77 Ø:2.6 cm, L:30 cm (Drawing 5500-000016-1A) .
- FreeeScan® 84 Ø:3 cm, L:30 cm (Drawing 5500-000015-1A) .
All of these versions are composed of the same materials, they are made using the same processes and procedures, in the same facilities and on the same equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility tests for cytotoxicity, irritation, sensitisation, and ethylene oxide sterilization residuals have demonstrated the FreeeScan® chloroprene material/cover device is: Severely cytotoxic, Non-sensitizing, Non-irritating. Testing is in accordance with - ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP). Type I natural latex allergy does not occur in response to chloroprene synthetic rubber.
The FreeeScan® Ultrasound Transducer Cover has a nominal thickness of 0.2 mm. The FreeeScan® Ultrasound Transducer Cover provides an effective barrier to prevention of microbial migration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Ascendia. The logo consists of a stylized letter "A" on the left and the word "ASCENDIA" in bold, sans-serif font on the right. The letter "A" is formed by two intersecting curves, creating a dynamic and modern design.
AUG 1 5 2005 -
510(k) Summary
KO50320
12 January 2005
General Information
| Submitter's name: | Ascendia MedTech AB |
|---|---|
| Address: | Finlandsgatan 18, SE-164 74 Kista, Sweden |
| Telephone No: | +45 8 444 54 00 |
| Contact Person: | Anders Weiland |
| Establishment Registration | |
| Number: | 8032029 |
| Device Trade Name: | FreeeScan® Ultrasound Transducer Cover |
| Device Common Name: | Ultrasound Transducer Cover/Sheath/Drape |
| Device Classification Name: | Diagnostic Ultrasonic Transducer |
| Classification: | Class II (under 21 CFR 892.1570) |
| Classification Panel: | Radiology |
| Classification Procode: | ITX |
| Performance Standards: | No applicable standards have been issued |
| under Section 514 of the Food, Drug and | |
| Cosmetic Act. |
Subcontractors
Contracted Sterilizer:
Paper-Pak Sweden AB Jarnvagsgatan 34 311 22 Aneby Sweden Phone No. +46 380-475 00
Manufacturer:
Nolato Medevo AB 260 93Torekov Sweden Phone No. +46 431-44 22 90
Contact Name: Rickard Thorsen
Contact Name: Henrik Rosengren
ASCENDIA MEDTECH AB · FINLANDSGATAN 18 · SE164 74 · KISTA · SWEDEN PHONE:+46-8-444 5400 ・ FAX: +46-8-623 0972 EMAIL: info@ascendia.se · WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SE556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA.
1
- 2 -
28 January 2005
Repackager:
TotalLoqistik Box 143 311 22 Falkenberg Sweden Phone No. +46 34-62 94 30
Contact Name: Jan Lindman
Device Description
The FreeeScan® Ultrasound Transducer Cover provides a thin, conformal covering to fit various ultrasound transducer geometries. The device is manufactured as a one-piece design that provides a covering to prevent the transmission of pathogens, as the ultrasound transducer is reused from one patient to another.
The cover material is Chloroprene (synthetic rubber), which is similar to the non-latex material used in medical examination gloves or surgical gloves. Type I natural latex allergy does not occur in response to Chloroprene since the synthetic rubber does not contain the natural protein allergen which is present in latex.
Various sizes and shapes of covers are offered in order to fit different transducer geometries. The following product models are currently included (other shapes are likely to be added):
- . FreeeScan® 1 - W:3.4 cm, L:45-244 cm (Drawing 5500-000002-1B)
- FreeeScan® 4 W:10 cm, L:45-244 cm (Drawing 5500-000003-1B) .
- FreeeScan® 6 W:9.5/11.5 cm, L:45-244 cm (Drawing 5500-000004-1B) .
- . FreeeScan® 8 - W:7.5 cm, L:45-244 cm (Drawing 5500-000005-1B)
- FreeeScan® 77 Ø:2.6 cm, L:30 cm (Drawing 5500-000016-1A) .
- FreeeScan® 84 Ø:3 cm, L:30 cm (Drawing 5500-000015-1A) .
All of these versions are composed of the same materials, they are made using the same processes and procedures, in the same facilities and on the same equipment.
ASCENDIA MEDTECH AB · FINLANDSGATAN 18 · SE164 74 · KISTA · SWEDEN PHONE : + 46-8-444 5400 · FAX: + 46-8-623 0972 EMAIL: info@ascendia.se · WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SE556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA.
2
- 3 -
Intended Use of the Device
The FreeeScan® Ultrasound Transducer Covers are protective covers applied to ultrasound transducers. These covers are designed to provide a sterile barrier between the non-sterile TXD's (and instrument guide adapters in some cases) and the patient/healthcare worker. The covers are intended for use during both sterile and non-sterile procedures using sector, linear, intravaginal and rectal transducers.
The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive. The transducer covers are supplied sterile or non-sterile and intended for single-use.
Covers are packed in sterile or non-sterile "convenience" kits form for single patient/procedure, disposable use. Covers kits are supplied with needle guide devices, coupling gel packet, elastic bands, and tape.
Predicate Device
Ascendia MedTech AB believes that the FreeeScan® Ultrasound Transducer Cover is substantially equivalent to the CIVCO Medical's ultrasound transducer cover, NeoFlex™ Ultrasound Transducer Cover.
| Predicate Device | 510(k)
Reference | Manufacturer |
|-----------------------------------------|---------------------|---------------------------------------|
| NeoFlex™ Ultrasound Transducer
Cover | K991236 | CIVCO Medical, Inc
Kolona, IA, USA |
ASCENDIA MEDTECH AB · FINLANDSGATAN 18 · SE164 74 · KISTA · SWEDEN PHONE:+46-8-444 5400 ■ FAX: +46-8-623 0972 EMAIL: info@ascendia.se · WEBSITE: www.ascendia.se and www.amedic.se VAT NO. 5E556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: K1STA.
3
Substantial Equivalent Summary
Ascendia MedTech AB believes that the FreeeScan® Ultrasound Transducer Cover is substantially equivalent in safety and effectivness to the CIVCO Medical NeoFlex™ Ultrasound Transducer Cover. The following comparison table shows this substantial equivalence:
| Parameter | FreeeScan® Ultrasound
Transducer Cover | NeoFlex™ Ultrasound
Transducer Cover |
|----------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | Same | Provides a thin,
conformal protective
cover system for
diagnostic ultrasound
transducer usage in
body surface,
endocavity, and intra-
operative patient
environments; helps to
prevent transfer of
micro organisms, body
fluids, and particulate
material to the patient
and healthcare worker
during reuse of the
transducer, and helps
to maintain the sterile
field where applicable;
disposable device - for
single patient/procedure
use.
Is non-latex therefore
beneficial when treating
a patient with known
type I hypersensitivity,
or for the healthcare
worker who has
become type I
sensitised. |
| Design | The FreeeScan® Ultrasound
Transducer Cover is folded.
In other respects the same. | One-piece, closed end,
rolled (condom style)
with various
dimensional
configurations
necessary to
accommodate
differences in
ultrasound transducer
geometries. |
ASCENDIA MEDTECH AB • FINLANDSGATAN 18 • SE164 74 • KISTA • SWEDEN PHONE: + 46-8-444 5400 · FAX: + 46-8-623 0972 EMAIL: info@ascendia.se • WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SE556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA.
4
– 5 –
:
.
28 January 2005
| Parameter | FreeeScan® Ultrasound
Transducer Cover | NeoFlex™ Ultrasound
Transducer Cover |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Same | Polychloroprene,
synthetic rubber
Materials used in
compounding meet the
recommended safe
levels as specified in
the US Food and Drugs
Administration CFR,
Title 21, Section
177.2600 and
182.5991.
USP Absorbable
Dusting Powder
Synthetic rubber does
not contain the natural
protein allergen
residuals present in
latex. |
| Manufacturing | Packaged in class 100 000
clean room, otherwise the
same. | Dip-molding/rubber
vulcanisation
Packaged in class 10
000 clean room per
Federal Std 209e.
Packaging system per
ANSI/AAMI/ISO 11607 |
| Quality System | Same | FDA/QSR cGMP
21CFR Part 820.
ISO 9001/ISO
13485/EN 46001 |
| Sterility | Same | Sterilization (when
applicable) by
100%EtO method;
Validated
ANSI/AAMI/ISO 11135
SAL 106 |
| Parameter | FreeeScan® Ultrasound
Transducer Cover | NeoFlex™ Ultrasound
Transducer Cover |
| Contact
category | Same | Surface devices, intact
skin/mucosal
membranes/breached
surfaces; limited
contact duration ( ASCE NDIA MEDTECH AB • FINLANDSGATAN 18 • SE 164 74 • KISTA • SWEDEN PHONE:+46-8-444 5400 ● FAX: +46-8-623 0972 EMAIL: info@ascendia.se • WEBSITE: www.ascendia.se and www.amedic.se VAT NO. SE556236922201 . REG. NO. 556-236 9222. REGISTERED OFFICE: KISTA.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white.
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascendia MedTech AB % Ms. Jane B. Campbell President J & D Campbell Associates, Inc. 485 LaRoe Road CHESTER NY 10918
Re: K050320
Trade/Device Name: FreeeScan® Ultrasound Transducer Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: August 2, 2005 Received: August 3, 2005
Dear Ms. Campbell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
9
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be devilsed that I Dri breasures of the complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other federal agencies. You must or any I oderal bakated and sequirements, including, but not limited to: registration (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice 007); nounig (21 est forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet ronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling derive to processe contact the Office of Compliance at (240) 276-0100. Also, please note the regulation, produce conding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David R. Ingram
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Image /page/10/Picture/0 description: The image shows the word "ASCENDIA" in bold, sans-serif font. To the left of the word is a stylized graphic that resembles an infinity symbol or a sideways figure-eight. The graphic is also in bold and appears to be a single, continuous line. The overall impression is of a logo or brand mark.
Document Title 510(k) Application FreeeScan Chloroprene Cover Re Docu ent Nun 9000-000054 01
Statement of Indications for Use 1
Device name: FreeeScan® Ultrasound Transducer Cover
1.1 Indications for Use
The FreeeScan® Ultrasound Transducer Covers are protective covers applied to The I recobran o Cransducers. These covers are designed to provide a sterile barrier between the non-sterile transducer (and instrument guide adapters in some cases) and the patienthealthcare worker. The covers are intended for use during both sterile and nonsterile procedures using sector, linear, intravaginal and rectal transducers.
The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive.
The transducer covers are supplied sterile or non-sterile and intended for single-use.
Prescription use i
David R. Legron
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _